The present invention relates generally to the field of electrosurgery, and more particularly to surgical devices and methods which employ high frequency electrical energy to ablate, resect, coagulate, or otherwise modify a target tissue. The present invention also relates to apparatus and methods for the controlled removal of tissue at a target site by electrosurgical ablation (e.g., Coblation®), and for efficiently aspirating resected tissue from the target site, wherein the depth to which tissue is removed can be precisely controlled with minimal or no collateral damage, and all ablation by-products are removed via an aspiration unit.
Conventional electrosurgical methods generally reduce patient bleeding associated with tissue cutting operations and improve the surgeon's visibility. These electrosurgical devices and procedures, however, suffer from a number of disadvantages. For example, monopolar electrosurgery methods generally direct electric current along a defined path from the exposed or active electrode through the patient's body to the return electrode, which is externally attached to a suitable location on the patient's skin. In addition, since the defined path through the patient's body has a relatively high electrical impedance, large voltage differences must typically be applied between the active and return electrodes to generate a current suitable for cutting or coagulation of the target tissue. This current, however, may inadvertently flow along localized pathways in the body having less impedance than the defined electrical path. This situation will substantially increase the current flowing through these paths, possibly causing damage to or destroying tissue along and surrounding this pathway.
Bipolar electrosurgical devices have an inherent advantage over monopolar devices because the return current path does not flow through the patient beyond the immediate site of application of the bipolar electrodes. In bipolar devices, both the active and return electrode are typically exposed so that they may both contact tissue, thereby providing a return current path from the active to the return electrode through the tissue. One drawback with this configuration, however, is that the return electrode may cause tissue desiccation or destruction at its contact point with the patient's tissue.
Another limitation of conventional bipolar and monopolar electrosurgery devices is that they are not suitable for the precise removal (ablation) of tissue. For example, conventional electrosurgical cutting devices typically operate by creating a voltage difference between the active electrode and the target tissue, causing an electrical arc to form across the physical gap between the electrode and tissue. At the point of contact of the electric arcs with tissue, rapid tissue heating occurs due to high current density between the electrode and tissue. This high current density causes cellular fluids to rapidly vaporize into steam, thereby producing a “cutting effect” along the pathway of localized tissue heating. The tissue is parted along the pathway of vaporized cellular fluid, inducing undesirable collateral tissue damage in regions surrounding the target tissue site.
In addition, conventional electrosurgical methods are generally ineffective for ablating certain types of tissue, and in certain types of environments within the body. For example, loose or elastic connective tissue, such as the synovial tissue in joints, is extremely difficult (if not impossible) to remove with conventional electrosurgical instruments because the flexible tissue tends to move away from the instrument when it is brought against this tissue. Since conventional techniques rely mainly on conducting current through the tissue, they are not effective when the instrument cannot be brought adjacent to or in contact with the elastic tissue for a long enough period of time to energize the electrode and conduct current through the tissue.
The use of electrosurgical procedures (both monopolar and bipolar) in electrically conductive environments can be further problematic. For example, many arthroscopic procedures require flushing of the region to be treated with isotonic saline, both to maintain an isotonic environment and to keep the field of view clear. However, the presence of saline, which is a highly conductive electrolyte, can cause shorting of the active electrode(s) in conventional monopolar and bipolar electrosurgery. Such shorting causes unnecessary heating in the treatment environment and can further cause non-specific tissue destruction.
Conventional electrosurgical cutting or resecting devices also tend to leave the operating field cluttered with tissue fragments that have been removed or resected from the target tissue. These tissue fragments make visualization of the surgical site extremely difficult. Removing these tissue fragments can also be problematic. Similar to synovial tissue, it is difficult to maintain contact with tissue fragments long enough to ablate the tissue fragments in situ with conventional devices. To solve this problem, the surgical site is periodically or continuously aspirated during the procedure. However, the tissue fragments often clog the aspiration lumen of the suction instrument, forcing the surgeon to remove the instrument to clear the aspiration lumen or to introduce another suction instrument, which increases the length and complexity of the procedure.
Endometriosis is a common condition due to the presence of ectopic endometrial tissue, usually within the abdominal cavity, which can lead to infertility in women. Endometrial lesions or implants respond to ovarian hormonal changes, similar to the uterine endometrium. Symptoms of endometriosis include localized bleeding, pain, inflammation, scarring, and adhesion formation.
There is a need for improved treatment of endometriosis. Medical therapy for endometriosis is basically hormonal. Treatment with continuous progesterone can shrink endometriotic implants. Treatment that causes a significant decrease in estrogen levels (pseudomenopausal state) is generally more effective than a prolonged progesterone effect. Agents that suppress ovarian estrogen production include Danazol (a weak androgenic hormone), and Lupron (a gonadotropin-releasing hormone agonist). Prescription of such products is usually limited to periods of not more than six months due to their side effects (including bone demineralization and increased risk of cardiovascular disease). Often, the beneficial effects of such products are short-lived following cessation of treatment. Prior to recent advances in laparoscopic instrumentation and procedures, a common treatment for endometriosis was pelvic laparotomy. Lasers have been used for removal of endometrial lesions. However, in the context of surgical ablation, lasers suffer from a number of disadvantages, as outlined hereinabove. Thus, there is a need for improved electrosurgical instruments which allow the removal of ectopic endometrial tissue from various sites during minimally invasive laparoscopic procedures, wherein the target tissue is removed in a highly controlled manner with little or no collateral damage.
The instant invention provides methods and electrosurgical apparatus for the controlled removal or coagulation of target tissue during laparoscopic procedures with no or minimal damage to delicate, easily damaged underlying tissue.